PUMPKIN BACKGROUND UPDATE ON PUMPKIN TRIAL
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Update on PumpKIN Trial
Max B. Mitchell, MD
The Children’s Hospital Heart Institute
Professor of Surgery
University of Colorado Denver Health Science Center
PumpKIN Background
• 2002: NHLBI issued a Broad Agency
Announcement (BAA) entitled “Pediatric
Pediatric Circulatory
Support Program” (PCSP)
• Key Technical requirements of PCSP:
– Children 2-25 kg
– Durability of 6 months support
– Functioning within 1 hour
– Minimal prime volume
– Appropriate cannulation strategies
– Minimal blood product exposure
– Minimize risks of serious adverse eventsPCSP: At first there were 5
Pulsatile Pediatric VADs
Penn State University Awarded 2004 PediPump
Cleveland Clinic Foundation
$22 4 million
$22.4 illi
Infant Jarvik 2000
Jarvik Heart Inc.*
Pediatric Cardiopulmonary Assist System
PediaFlow
(pCAS) Ension, Inc.
Univ Pittsburgh*
PCSP begets PumpKIN
• 2004-2009: Engineering & device
development phase of 5 PCSP devices
• Oct 2008: NHLBI issued RFP called the
Pumps for Kids, Infants, and Neonates
(PumpKIN) Program
• Purposes:
– Support the pre-clinical work required for
contractors to obtain IDEs from the FDA
– Implement IDE clinical trials leading to FDA
device approval(s) under HDE guidelinesPumpKIN: then there were 4
• Jan 2010: NHLBI issued 4 awards:
– 3 of the PCSP Contractors:
• PediaFlow: University of Pittsburgh
• Infant Jarvik 2000: Jarvik Heart Corp
• pCAS: Ension, Inc
– 4th award went to new Contractor:
• PediPL: Pedi Pump-Lung,
Pump-Lung University of Maryland
• 2 axial flow VADS, 2 ACE systems
• Awards totaled $23.6 million
PumpKIN Program
• Dec 2010: NHLBI issued RFP for a Data
andd Cli
Clinical
i l Coordinating
C di ti C Center
t (DCCC) tto
manage the clinical phases of the
PumpKIN program
• April 2012: NERI (New England Research
Institute, Inc.) awarded the DCCC contract
• NERI’s award contract worth $18.8 millionSummer 2012
PediPL
PediaFlow Univ Maryland
Univ Pittsburgh
Infant Jarvik 2000 pCAS
Jarvik Heart, Inc. Ension, Inc.
DCCC
PumpKIN 2012
• June 2012: NERI contacted potential
clinical sites to solicit interest and
information regarding institutional
support for PumpKIN
• 4 devices (2 VADs, 2 ACE systems)PumpKIN 2013: then there were 3
• Jan 2013: NERI provided an update to
potential
t ti l clinical
li i l sites
it att th
the S
Society
i t off
Thoracic Surgeons Annual Meeting
– 3 devices, 2 prospective randomized trials:
• Jarvik 2000 vs. Berlin Heart Excor control group
• pCAS & PediPL vs. conventional ECMO control
• PediaFlow absent from update documents
PediaFlow VAD eliminated
Aug 2012PumpKIN 2013
• Feb 2013: clinical site applications distributed by
NERI
• Mar 2013: site applications submitted
• June 2013: NERI announced selection of 22 sites
PumpKIN Clinical Sites
Site Surgical PI Cardiology PI
A.I. duPont Hospital for Children Christian Pizarro, MD Michael McCullogh, MD
Arkansas Children's Hospital Michiaki Imamura, MD, PhD Elizabeth Frazier, MD
Boston Children's Hospital Francis Fynn-Thompson, MD Christina VanderPluym, MD
Children's Healthcare of Atlanta Kirk Kanter, MD Shriprasad Deshpande, MD
Children's Hospital Colorado Max Mitchell, MD Scott Auerbach, MD & Shannon Buckvold, MD
Children's Hospital of Philadelphia (CHOP) William Gaynor, MD Joseph Rossano, MD
Children's Hospital of Wisconsin James Tweddell, MD Nancy Ghanayem, MD
Children's Medical Ctr, Dallas Kristine Guleserian, MD Aliessa Barnes, MD
CHONY-Columbia University Medical Center Emile Bacha, MD Marc E. Richmond, MD, MS
Cincinnati Children's Hospital David Morales, MD Angela Lorts, MD
Duke University Hospital Andrew Lodge, MD Michael Carboni, MD
Hospital for Sick Children, Toronto Glen Van Arsdell, MD Tilman Humpl, MD, PhD
Lucile Packard Chidlren's Hospital, Stanford University Olaf Reinhartz, MD David Rosenthal, MD
Monroe Carell Children
Children's
s Hospital
Hospital, Vanderbilt University Bret Mettler,
Mettler MD Debra Dodd,
Dodd MD
Nationwide Children's Hospital Patrick McConnell, MD Timothy Hoffman, MD
Seattle Children's Hospital David M. McMullan, MD Sabrina Law, MD
St. Louis Children's Hospital Wash U. St. Louis Pirooz Eghtesady, MD, PhD Charles Canter, MD
Stollery Children's Hospital, Edmonton Ivan Rebeyka, MD Holger Buchholz, MD
Charles Fraser, MD & Iki Adachi,
Texas Children's Hospital MD Aamir Jeewa, MD
University of Alabama, Birmingham James Kirklin, MD F. Bennett Pearce, MD
University of Michigan C.S. Mot Children's Hospital Richard Ohye, MD Robert Gajarski, MD
University of Minnesota Amplatz Children's Hospital James D. St. Louis, MD Rebecca K. Ameduri, MDPumpKIN 2013: then there were 2
• June 2013 site announcement indicated
th t P
that PumpKIN
KIN will
ill iinvolve
l 2ddevices,
i 2
trials:
• VAD: Jarvik 2000 vs. Berlin Heart Excor
• ACE: PediPL vs. conventional ECMO
• All sites will participate in each trial (VAD, &
ACE)
• Ension’s pCAS eliminated
Ension pCAS eliminated
• Additional Costs and Time
needed for preclinical
development
• Ension determined they would
not be able to meet the
contracted IDE application
timelineWhere does PumpKIN stand
now?
Nov 2013: and then there was 1
• L
Lastt weekk Th
Thoratec
t withdrew
ithd th
the P
PediPL
diPL from
f
PumpKIN
• Technical issues?The last man standing
Planned PumpKIN VAD
Protocol
PumpKIN
(Infant Jarvik 2000)
Prospective
Trial Design
Two-Arm
Randomized to
Control
Berlin Heart EXCOR
Patient Size ≤ 0.8 m2
Patient Weight > 4 Kg and < 15 Kg
HF Diagnosis Severe 2 Vent
Severe, Vent. HF
Sample Size 44/group*
Centers 22
Primary Probable Benefit Survival w/out new severe
Endpoint NI at 180 days
Primary Safety Endpoint SAE rate for 180 daysLatest PumpKIN Timeline
IDE Applications
IDE Approvals (Contingent on FDA Decision)
2013 2014 2015 2016 2017 2018
Phase I Phase II Phase III
Clinical
Cli i l Trials
Ti l
Protocol Development Data Analyses
Clinical Site Prep Publications
Training HDE Applications
Summary of current
PumpKIN status
• NHLBI review of protocols complete
• FDA Pre-IDE review of protocols complete
• Clinical sites selected
• DSMB Appointed
• Site training planned (March 2014)
• Devices and Timing of IDE(s) uncertainYou can also read
